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news.Avax Technologies has received FDA approval to begin enrollment into a Phase I-II clinical trial of OVax for patients with advanced, chemotherapy-refractive ovarian cancer.
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The study will be performed in collaboration with Cancer Treatment Centers of America (CTCA). Up to 42 eligible patients with stage III or IV ovarian carcinoma will be enrolled. These patients’s cancers will have progressed despite initial surgery and chemotherapy and failed to respond to one or two salvage chemotherapy regimens. They will undergo debulking surgery, and tumor tissue will be sent to Avax for production of vaccine. Post-operatively, they will receive intraperitoneal chemotherapy with a taxane and then will be enrolled into the protocol.
Three doses of OVax will be tested, and each of the three doses will be analyzed for immunological efficacy with the goal of optimizing the dose for treatment of patients in future trials.
David Berd, chief medical officer of Avax, said: “This alliance with CTCA will allow us to expand the therapeutic utility of the AC Vaccine platform along with our ongoing Phase I/II program in non-small cell lung cancer and our recently launched Phase III pivotal registration study in melanoma(MVALDI).”